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Cera™ Vascular Plug System Post-Market Clinical Follow-Up

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Eligibility criteria expanded, about 18 wordsv6
  2. Primary completion pushed from Dec 2026 to Jun 30, 2027
    • Study completion pushed from Dec 2027 to Jun 30, 2028
    • Site details revised at 1 of 9 sites
    v5
  3. Trial sites expanded: 4 → 9 locationsv4
  4. Primary completion date: Jun 2025 to Dec 2026
    • Study sites: 1 to 4
    • Study completion date: Jun 2026 to Dec 2027
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2024 to Jun 21, 2024
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: * confirm the performance * confirm the safety * identify previously unknown side-effects * monitor the identified side-effects (related to the procedures or to the medical devices) * identify and analyse emergent risks
Trial Details
NCT Number NCT06099015
Lead Sponsor Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions
(from sponsor)		 Aneurysm, Endoleak, Pulmonary Arteriovenous Malformation, Portal Hypertension, Arteriovenous Fistula, Splenic Laceration
Related terms Aneurysm, Arteriovenous Fistula, Endoleak, Hypertension, Portal, Pulmonary Arteriovenous Fistulas
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov